País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
CICLOPIROX OLAMINE (UNII: 50MD4SB4AP) (CICLOPIROX - UNII:19W019ZDRJ)
Padagis Israel Pharmaceuticals Ltd
CICLOPIROX OLAMINE
CICLOPIROX 7.70 mg in 100 mL
TOPICAL
PRESCRIPTION DRUG
Ciclopirox Olamine Topical Suspension USP, 0.77% (w/w) (Lotion) is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis; cutaneous candidiasis (moniliasis) due to Candida albicans; and tinea (pityriasis) versicolor due to Malassezia furfur . Ciclopirox Olamine Topical Suspension USP, 0.77% (w/w) (Lotion) is contraindicated in individuals who have shown hypersensitivity to any of its components.
Ciclopirox Olamine Topical Suspension USP, 0.77% (w/w) (Lotion) is available as follows: 30 mL bottle (NDC 45802-400 -49) 60 mL bottle (NDC 45802-400 -46) Bottle space provided to allow for vigorous shaking before each use.
Abbreviated New Drug Application
CICLOPIROX OLAMINE- CICLOPIROX OLAMINE SUSPENSION PADAGIS ISRAEL PHARMACEUTICALS LTD ---------- CICLOPIROX OLAMINE TOPICAL SUSPENSION USP, 0.77% (W/W) (LOTION) RX ONLY FOR DERMATOLOGIC USE ONLY. NOT FOR USE IN EYES. DESCRIPTION Ciclopirox Olamine Topical Suspension USP, 0.77% (w/w) (Lotion) is for topical use. Each gram of Ciclopirox Olamine Topical Suspension USP, 0.77% (w/w) (Lotion) contains 7.70 mg of ciclopirox (as ciclopirox olamine) in a water miscible suspension base consisting of benzyl alcohol (1% as a preservative), cetyl alcohol, lactic acid, light mineral oil, myristyl alcohol, octyldodecanol, polysorbate 60, purified water, sorbitan monostearate, and stearyl alcohol. Ciclopirox Olamine Topical Suspension USP, 0.77% (w/w) (Lotion) contains a synthetic, broad-spectrum, antifungal agent ciclopirox (as ciclopirox olamine). The chemical name is 6-cyclohexyl-1-hydroxy-4-methyl-2(1_H_)-pyridone, 2-aminoethanol salt. The CAS Registry Number is 41621-49-2. Ciclopirox Olamine Topical Suspension USP, 0.77% (w/w) (Lotion) has a pH of 7. The chemical structure is: CLINICAL PHARMACOLOGY Ciclopirox is a broad-spectrum, antifungal agent that inhibits the growth of pathogenic dermatophytes, yeasts, and _Malassezia furfur_. Ciclopirox exhibits fungicidal activity _in_ _vitro _against isolates of _Trichophyton rubrum, Trichophyton mentagrophytes,_ _Epidermophyton floccosum, Microsporum canis, _and _Candida albicans._ Pharmacokinetic studies in men with radiolabeled ciclopirox solution in polyethylene glycol 400, showed an average of 1.3% absorption of the dose when it was applied 2 topically to 750 cm on the back followed by occlusion for 6 hours. The biological half-life was 1.7 hours and excretion occurred via the kidney. Two days after application only 0.01% of the dose applied could be found in the urine. Fecal excretion was negligible. Autoradiographic studies with human cadaver skin showed that ciclopirox penetrates into the hair and through the epidermis and hair follicles into the sebaceous glands and dermis, Leia o documento completo